Description

Lead computer systems validation (CSV) activities to ensure regulatory compliance and meet production schedules.

Responsibilities

• Lead CSV commissioning and qualification activities for lab and manufacturing systems.
• Review and execute validation lifecycle documentation, including strategies, plans, protocols, and summary reports.
• Identify regulatory risks and implement appropriate remediation strategies across sites.
• Execute installation, operational, and performance qualifications in accordance with cGMP.
• Manage validation deviations and implement corrective and preventive actions.

Required Skills

• 10 to 15+ years of experience in the pharmaceutical industry focusing on quality and regulatory compliance.
• Mandatory end-to-end computerized system validation experience.
• Deep knowledge of software lifecycle approaches including GAMP5, Agile, and Waterfall.
• Expertise in regulatory requirements including Annex EU 11, PIC/S, and 21 CFR Part 11.
• Working knowledge of validation principles, cGMPs, FDA, EMA, TGAs, and ICH guidelines.
• Ability to plan and organize validation activities across cross-functional groups.
• Strong understanding of validation governance and principles.

Preferred Skills

• Master’s Degree.
• In-depth knowledge of pharma quality systems and validation strategies for lab and manufacturing systems.
• Understanding of risk management and its application in design and quality systems.

Key Skills

Education

Not specified